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临床试验/NCT02219308
NCT02219308已完成不适用

Pain Control for Intrauterine Device Placement: A Randomized Controlled Trial of Paracervical Block

University of California, San Diego4 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
4
主要终点
Pain With Intrauterine Device (IUD) Placement

研究概览

简要总结

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

详细描述

Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement. Studies to evaluate effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed.

Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous women
  • English or Spanish speaking
  • Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

排除标准

  • Pregnancy
  • Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
  • If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
  • Misoprostol administration within 24 hours of enrollment
  • History of prior IUD insertion
  • Known contraindications to IUD

研究组 & 干预措施

Paracervical Block (PCB)

Experimental

Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.

Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.

干预措施: Paracervical Block (PCB) (Procedure)

No Paracervical Block (Sham PCB)

Sham Comparator

Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.

Subject then receives Sham paracervical block with capped needle. Provider then places IUD.

干预措施: No Paracervical Block (Sham PCB) (Procedure)

结局指标

主要结局

Pain With Intrauterine Device (IUD) Placement

时间窗: Moment of IUD insertion

Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.

次要结局

  • Median Pain Scores for All Time Points(Anticipation of procedure through 5 minutes after IUD placement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Mody

Women's Reproductive Health Research (K12) Scholar

University of California, San Diego

研究点 (4)

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